| CTRI Number |
CTRI/2018/12/016516 [Registered on: 03/12/2018] Trial Registered Prospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Electronic Monitoring System for Surgical Site Infections |
|
Scientific Title of Study
|
Development and Validation of an Electronic Surveillance System for Surgical Site Infections developing during hospital stay and after discharge: A Multi-Centric Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
2nd Floor
Basic Sciences Building
Department of Microbiology
Kasturba Medical College
Manipal
2nd Floor
Basic Sciences Building
Department of Microbiology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chranjay.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
2nd Floor
Basic Sciences Building
Department of Microbiology
Kasturba Medical College
Manipal
2nd Floor
Basic Sciences Building
Department of Microbiology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chranjay.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
2nd Floor
Basic Sciences Building
Department of Microbiology
Kasturba Medical College
Manipal
2nd Floor
Basic Sciences Building
Department of Microbiology
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chranjay.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
New Delhi
India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chiranjay Mukhopadhyay |
Kasturba Hospital |
Room No 9
Administrative Block
KMC
Udupi
KARNATAKA |
9845513057
chiranjay.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing the surgery and who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Immunodeficiency patients and patients with prior surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the prevalence of SSIs
To determine the pathogens causing SSIs
To validate the electronic Surveillance System |
During the patient stay in hospital daily monitoring of laboratory reports will be done.
Post-discharge data will be gathered by telephone and postal questionnaires
At 30th day (first time), 60 days (second time), 6 months (third time) and 12 months (final follow-up in case of implant surgery) after the operation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post discharge data |
At 30th day (first time), 60 days (second time), 6 months (third time) and 12 months (final follow-up in case of implant surgery) after the operation. |
|
|
Target Sample Size
|
Total Sample Size="45000"
Sample Size from India="45000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Development and validation of an Electronic Surveillance System for the Surgical Site Infections developing during hospital stay and after discharge |